Effect of Evobrutinib on Pharmacokinetics of a Combined Oral Contraceptive

Merck KGaA (EMD Serono)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Evobruitnib; Drug: Combined oral contraceptive [ethinyl estradiol/ norethisterone (EE/NET)]

Study type: Interventional

Funder types: Industry

Identifiers

NCT07215806

2022-000124-38 (EudraCT Number)

MS200527_0079

Details and patient eligibility

About

The purpose of this study was to assess the effect of M2951 on the pharmacokinetics (PK) of a combined oral contraceptive [Ethinyl estradiol/Norethisterone (EE/NET)] in healthy female participants.

• Study Duration: up to 46 days
• Treatment Duration: Days 4 to 17 (14 days treatment with M2951); Days 1 and 15 (2 days treatment with Combined Oral Contraceptive [COC])
• Visit Frequency: Participants were resident in the Clinical Research Unit from Day -1 to Day 18.

Enrollment: 20 patients

Sex: Female

Ages: 18 to 68 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants are overtly healthy as determined by medical evaluation, including no clinically significant abnormality identified on physical examination or laboratory evaluation and no active clinically significant disorder, condition, infection or disease that would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion
• Participants have a body weight within 50.0 and 100.0 kilograms (kg) (inclusive) and body mass index within the range 19.0 and 30.0 kilograms per square meter (kg/m^2) (inclusive)
• Participants are nonsmokers for at least 6 months preceding Screening
• Female participants who are not a Woman of Childbearing Potential (WOCBP)
• Other protocol defined inclusion criteria could apply

Exclusion criteria

• Participants with history or presence of clinically relevant respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders, as determined by medical evaluation
• Participants with diagnosis of hemochromatosis, Wilson´s disease, alpha 1 antitrypsin deficiency, or any other chronic liver disease including Gilbert's disease will be excluded from the study
• Participants with prior history of splenectomy or any clinically relevant surgery within 3 months prior to Screening
• Participants with history of any malignancy
• Participants with history of chronic or recurrent acute infection or any bacterial, viral, parasitic, or fungal infections within 30 days prior to Screening and at any time between Screening and admission, or hospitalization due to infection within 6 months prior to Screening
• Participants with history of shingles within 12 months prior to Screening
• Administration of live vaccines or live-attenuated virus vaccines within 3 months prior to Screening. Administration of other types of vaccines [e.g., Severe acute respiratory syndrome coronavirus 2 (SARSCoV2) vaccines] is allowed until 4 weeks before admission to CRU, thereafter it is prohibited until the end of the study
• Note: In case of clinical symptoms, the participant should be symptom-free for at least 1 week prior to admission to Clinical Research Unit (CRU)
• Other protocol defined exclusion criteria could apply

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

COC + Evobrutinib

Experimental group

Description:

Participants received combined oral contraceptive (COC) \[0.03 milligrams (mg) of Ethinyl Estradiol (EE)\], 0.5 mg of Norethisterone (NET)\] orally on Day 1 and 15 in combination with Evobruitnib at a dose of 45 mg orally twice daily on Days 4 to 17.

Treatment:

Drug: Combined oral contraceptive [ethinyl estradiol/ norethisterone (EE/NET)]

Drug: Evobruitnib